European guidance for management clinical trials during corona crisis
The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published a guidance for sponsors and investigators on how to manage the conduct of clinical trials during the coronavirus disease (COVID-19) pandemic.
The guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations, e.g. if trial participants need to be in self-isolation or quarantine or if access to hospitals is temporarily limited.
This guidance includes a harmonised set of recommendations, to ensure the utmost safety of trial participants across the European Union while preserving the quality of the data generated by the trials. Also, the guideline contains specific advice on the initiation of new clinical trials for treatments of COVID-19, and in particular for large, multinational trial protocols.